QA & Compliance Associate

Acrosian LLC; India; Remote; INR 1,200,000 - 1,800,000; Full time

Job summary

Acrosian is an AI-augmented biometrics CRO building its quality management system from the ground up. The QA & Compliance Associate will own controlled documents, training records, audit logistics, and CAPA follow-through to keep the QMS inspection-ready as the company scales.

This is a build role, not a maintenance role, working within a global quality function serving delivery teams in India, Europe, and the United States.

Qualifications

• B.Pharm / M.Pharm, M.Sc. in life sciences, or equivalent.
• ISO 9001 and/or ISO 27001 Certifications OR, ISO/IEC 42001 (AI management system) Certifications preferred
• 2–5 years in QA or compliance within a CRO, pharmaceutical, biotechnology, or medical device organization.
• Working knowledge of ICH GCP and 21 CFR Part 11.
• Hands-on experience with an electronic QMS.
• Meticulous follow-through with senior stakeholders on overdue commitments.
• Demonstrated ability to work effectively in a fully remote, distributed team.
• Willingness to overlap several hours daily with US Eastern and European working hours.

Responsibilities

• Administer the electronic Quality Management System (ZenQMS): document lifecycle from draft through periodic review, workflow configuration, and user administration.
• Maintain the controlled document numbering scheme, revision history, and effective and retirement dates.
• Own the training matrix — assign, track, and elevate overdue curricula; maintain training records for employees and contractors across India, Europe, and the United States.
• Support sponsor audits and regulatory inspections, including preparation, document retrieval, response tracking, and remote audit logistics.
• Support vendor qualification assessments — questionnaires, evidence review, findings trackers, CAPA verification, and requalification scheduling.
• Assist with internal audits against the approved audit schedule and track findings to closure.
• Log, triage, track deviations, non-conformances, and CAPAs; drive owners to on-time closure and verify effectiveness.
• Escalate trends and recurring issues to the Chief Audit and Compliance Officer.
• Support compliance activities under ICH E6(R3), Indian GCP and the New Drugs and Clinical Trials Rules, 2019, and 21 CFR Part 11.
• Support data protection compliance under the Digital Personal Data Protection Act, 2023, and the GDPR for EU-sourced clinical data.
• Assist with computer system validation documentation and periodic system reviews.
• Support responses to sponsor quality and data security questionnaires.
• Support compliance monitoring for internal AI usage policies as those systems are deployed.

Skills

Strong written English

Remote collaboration

Stakeholder communication

Education

B.Pharm / M.Pharm, M.Sc. in life sciences, or equivalent

Tools

ZenQMS

Job description

Acrosian is an AI-augmented biometrics CRO building its quality management system from the ground up. The QA & Compliance Associate is the day-to-day engine of that system — owning controlled documents, training records, audit logistics, and CAPA follow-through so that the QMS remains inspection-ready as the organization scales.
This is a build role, not a maintenance role. The incumbent will be writing and administering processes that do not yet exist, working within a global quality function that serves delivery teams in India, Europe, and the United States.

Document and Training Control

• Administer the electronic Quality Management System (ZenQMS): document lifecycle from draft through periodic review, workflow configuration, and user administration.
• Maintain the controlled document numbering scheme, revision history, and effective and retirement dates.
• Own the training matrix — assign, track, and elevate overdue curricula; maintain training records for employees and contractors across India, Europe, and the United States.

Audit and Vendor Oversight

• Support sponsor audits and regulatory inspections, including preparation, document retrieval, response tracking, and remote audit logistics.
• Support vendor qualification assessments — questionnaires, evidence review, findings trackers, CAPA verification, and requalification scheduling.
• Assist with internal audits against the approved audit schedule and track findings to closure.

Quality Events

• Log, triage, track deviations, non-conformances, and CAPAs; drive owners to on-time closure and verify effectiveness.
• Escalate trends and recurring issues to the Chief Audit and Compliance Officer.

Compliance Support

• Support compliance activities under ICH E6(R3), Indian GCP and the New Drugs and Clinical Trials Rules, 2019, and 21 CFR Part 11.
• Support data protection compliance under the Digital Personal Data Protection Act, 2023, and the GDPR for EU-sourced clinical data.
• Assist with computer system validation documentation and periodic system reviews.
• Support responses to sponsor quality and data security questionnaires.
• Support compliance monitoring for internal AI usage policies as those systems are deployed.

Required

• B.Pharm / M.Pharm, M.Sc. in life sciences, or equivalent.
• ISO 9001 and/or ISO 27001 Certifications OR, ISO/IEC 42001 (AI management system) Certifications preferred
• 2–5 years in QA or compliance within a CRO, pharmaceutical, biotechnology, or medical device organization.
• Working knowledge of ICH GCP and 21 CFR Part 11.
• Hands-on experience with an electronic QMS.
• Strong written English — SOPs, audit reports, and CAPA records are writing tasks.
• Meticulous follow-through, including the confidence to pursue senior stakeholders on overdue commitments.
• Demonstrated ability to work effectively in a fully remote, distributed team.
• Willingness to overlap several hours daily with US Eastern and European working hours.

Preferred

• Experience in clinical data management, biostatistics, or statistical programming environments.
• Exposure to computer system validation, data integrity (ALCOA+), or information security frameworks.
• Familiarity with ZenQMS.
• Certification, or demonstrable progress toward certification, as CQA, CISA, or RAC.
• A strategic thinker with a hands-on leadership approach.
• A strong people leader with a track record of building and developing high-performing teams.
• Someone who can prioritize competing business needs, manage risk proactively, and drive execution in a fast-paced environment.
• A genuine customer focus and the ability to build trusted, long-term sponsor relationships.
• Passion for operational excellence, innovation, and continuous improvement.

Ready to lead this work?

If this sounds like the work you want to be doing, we would love to hear from you.
Acrosian is an equal opportunity employer.